Navigating the Regulatory Landscape for Innovative Biomedical Applications

NXTGEN Hightech Biomedical and High Tech NL invite you to join us for an insightful webinar on September 4, 2024, from 16:00 to 17:00 CET. This engaging and practical webinar will feature hands-on advice drawn from the extensive experience of QServe, a leading consultancy in regulatory affairs. Attendees will gain valuable insights into:

• The importance of early regulatory involvement
• Essential milestones necessary for preparing the launch of your biomedical innovations

📆 04-09-2024

🕒 16:00 – 17:00

📍 Online

Who Should Attend?

This webinar is designed for professionals in the fields of Biomedical Engineering, Applications, and Life Sciences who are keen to navigate the complex regulatory landscape and successfully bring their innovations to market.

Programme:

• Welcome by Edwin Roovers, High Tech NL Life Science
• How to bring your idea to the market 
  • Which is the first country I want to market my device?
  • Classification > Do I have a device?
  • High level overview IVDR, MDR, FDA
  • Manufacturing & responsibilities
  • Choosing suppliers, subcontractors and OEM’s
• Case study lab-on-chip 
  • Early phases what’s important
  • What is worth investigating
  • Common mistakes
  • Time vs cost
  • Exit strategy
• Q&A

Don’t miss this opportunity to enhance your understanding of regulatory requirements and accelerate your path to market success.

We look forward to your participation. Please register via this link. Register on time because there are limited spots available for this webinar.